Medical device with container rupturing means



' May 19, 1970 y DRII-:wE A 3,512,524

MED-ICAI.; DEVICE WITH CONTAINER RUPTURING MEANS Filed March 6, 1968 2Sheets-Sheet 1 J. nrEwE May 19,1970- 3,512,524 MEDICAL. nEvIcE WITHCONTAINER nupwnmdums med uam e, 196e 2 Sheets-Shut .2 l

United States Patent Office i 3,512,524 Patented May 19, 1970 3,512,524MEDICAL DEVICE WITH CONTAINER RUPTURING MEANS John Drewe, Bunh'ngford,England, assignor to Globampoule, A.G., Chur, Switzerland .Filed Mar. 6,1968, Ser. No. 711,044 Claims priority, application Great Britain, Mar.14, 1967, 11,983/ 67 Int. Cl. A61m 5/18 U.S. Cl. 12S-216 6 ClaimsABSTRACT F THE DISCLOSURE lThe container of a hypodermic syringe oreye-drop dispenser has a hollow projection on the end of which 1 sscrewed a nozzle having a hollow needle mounted in 1ts tip and pointingtowards the projection. Removably tted on a cylindrical part of thecontainer adjacent the base of the projection is a cover for theprojection and nozzle. Rotation of the cover in a given direction firstacts through a driving connection to screw the nozzle further onto theprojection, causing the needle to pierce the end of the latter, and thenfrees the driving connection to facilitate removal of the cover.

BACKGROUND OF THE INVENTION This invention relates to medicalappliances, such as hypodermic syringes and eye drop dispensers of thekind which, when supplied to the user, have a hollow needle arrangedwith a pointed end thereof directed towards, but spaced from, a sealedcontainer and which are prepared for use by causing the needle to bedisplaced relatively to the container so that the said pointed end ofthe needle pierces the container, thereby establishing communicationbetween the bore of the needle and the interior of the container.

In known hypodermic syringes of this kind for administering injections,the container is filled by the manufacturer under sterile conditionswith a predetermined quantity of a liquid medicament before beingsealed, the hollow needle is pointed at both ends and the pointed endpart remote from that which is directed towards the sealed containerprojects externally from the syringe, and this externally projecting endpart is enclosed within a removable hollow cap or cover to protect itfrom contamination.

If, however, such a syringe is to be used for taking and storingspecimens of blood or other body fluids, the container, before beingsealed, instead of being filled with a liquid medicament, may be eitherwholly or partly lled with air or may be collapsed and evacuated.

Eye drop dispensers of the kind referred to are generally similar to theknown hypodermic syringes described above, except that the externallyprojecting pointed end part is dispensed with and replaced by an outletend enclosed within and terminating flush with the outlet end of anozzle part of the body of the dispenser.

With appliances of this kind, the sealed container can be produced understerile conditions by the manufacturer and the externally projecting endpart of the needle or the nozzle end, in the case of eye dropdispensers, is protected from contamination by the cap or cover untilthe latter is removed. Hitherto, however, diliculty has been experiencedin avoiding a break in the sterile chain during the period beginningwith the manipulations for causing the needle to pierce the containerand ending withV the moment when the needle is injected into thepatients body in the case of an injection syringe or device for takingand storing body uids or when the eye drops are administered to thepatient in the case of an eye drop dispenser.

The main object of the present invention is therefore to prov1de animproved medical appliance of the kind referred to whereby thisdithculty is obviated.

SUMMARY OF THE INVENTION The medical appliance according to thisinvention includes a sealed, flexible-walled, hollow container having aclosed-ended, screw-threaded hollow projection, a needle mounting ofrelatively rigid material having an internal screw-thread engaged withthe outer end part of the screw-thread on the hollow projection, ahollow needle mounted in the outer end part of the needle mounting andhaving a pointed end part extending through the interior thereof towardsthe closed end of the hollow projection and a hollow cover enclosing thehollow projection, the needle mounting and the hollow needle, thecontainer having an annular thrust surface for locating the cover, andthe cover and the needle mounting being interconnected by a rotarydriving connection allowing axial sliding movement between them and soarranged that it becomes disengaged when the needle mounting has beenscrewed a predetermined distance along the projection towards thecontainer so as to cause the hollow needle to pierce the closed end ofthe hollow projection.

BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of thisinvention will now be described by way of example with reference to theaccompanying drawing in which:

`FIG. 1 is an axial cross-section illustrating a hypodermic syringeaccording to one embodiment of this invention,

FIG. 2 is a cross-section on the line II--II in FIG. 1,

FIG. 3 is an axial cross-section illustrating an eye-drop dispenseraccording to a further embodiment of this in` vention,

FIG. 4 is a side elevation of the eye-drop illustrated in FIG. 3 afterpreparation for use except for the removal of a cover shown inchain-dotted lines,

FIG. 5 is an axial cross-section corresponding to FIG. 3 illustrating amodification ofthe eye-drop dispenser shown in that figure, and

FIG. 6 is a side elevation corresponding to FIG. 4 of the eye-dropdispenser illustrated in FIG. 5.

DESCRIPTION OF SPECIFIC EMBODIMENTS In FIGS. 1 and 2 a flexible, hollow,bellows-type co1- lapsible container made, for example, frompolyethylene is shown at 1. This container 1 is provided at one endVwith an operating stud 2 and at the other end with a closed-endedhollow projection 3.

The hollow projection 3 is made with a six-start external screw thread 4which engages with a corresponding internal screw thread of a needle hub5.

The needle hub 5 coaxially supports a hollow needle 6 which is pointedat both ends so that, when the hollow projection 3 of the container 1 isscrewed into the needle hub 5 more than a pre-determined distance, theneedle 6 will pierce the closed end of the nozzle 3 of the container.The needle hub 5 is made of a rigid material such as, for example,polystyrene and is provided with line longitudinal serrations, shown at7.

A protective cover 8 made of a soft flexible material such as, forexample, polyethylene is fitted over the needle hub S so as to engageclosely with the longitudinal serrations 7. The serrated portion of theneedle hub and the portion of the protective. cover engaged therewithare tapered inwardly at a small angle n the direction away from thecontainer.

Connected by a ratchet-toothed coupling 10 to the cover 8 is a hollowfinger grip unit 9 which rests against 3 a frusto-conical surface on thefront end of the container 1 and encloses the greater part of saidcontainer.

When supplied ready for use, the container 1 is sealed with the druginside, the needle hub with the needle '6 mounted therein is screwedonto the hollow projection 3 of the container 1 such a distance that thepointed rear end of the needle is close to, but not in contact with, theclosed end of the hollow projection 3 and the cover 8 is pushed over theneedle hub 5, tightly engaging the serrations. The whole assembly isthen sealed in an outer package (not shown), typicallyaluminium/polyethylene foil laminate, and the entire package issterilized by gamma radiation.

To use the device, the outer wrapping is removed andv discarded. Thedevice can then safely be handled since the hollow projection 3, needlehub 5 and needle 6 are protected from the users hands by means of thecover 8. To pierce the end of the hollow projection 3 and at the sametime remove the cover 8, the finger grip unit 9 is turned clockwiserelatively to the cover 8, as a result of which the needle hub 5 isscrewed further onto the hollow projection 3. The rotation of the cover8 is transmitted to the needle hub 5 by the engagement of thelongitudinal serrations 7 in the latter with the soft material of thecover, while at the same time these serrations allow longitudinalmovement of the cover 8 relative to the needle hub 5. When the cover 8is rotated clockwise relatively to the container 1, the needle hub 5 isscrewed onto the nozzle 3, thus causing the rear end of the needle `6 topenetrate through the end of the hollow projection 3, but since thecover 8 is prevented from moving closer to the container 1 by theabutment of the finger grip unit 9 against the container 1, the needlehub 5 will move towards the open end of the cover 8 and at apredetermined position will lose its frictional engagement with thecover 8 which can then be removed. The removal of the cover 8 from theneedle hub 5 is facilitated by the fact that, as already mentioned, boththe inside of the cover 8 and the serrated portion 7 of the needle hub 5are formed with a slight inward taper in the direction away from thecontainer 1, or by forming the cover with an enlarged diameter bore 11near its rear end, or by a combination of both means as illustrated. Thefinal breaking of the frictional engagement takes place when the needlehub 5 is screwed fully home, so that rotation of the needle hub 5relatively to the cover 8 must take place if the action of rotatingcover 8 relatively to the container 1 is continued.

When the cover 8 comes away, the needle hub 5 rwill have been firmlyscrewed onto the nozzle 3, thus covering the screw thread 4 on thelatter and producing a rigid assembly.

The provision of the ratchet drive between the finger grip unit 9 andthe cover 8 ensures that the needle hub 5 will not he accidentallyunscrewed from the hollow projection 3 and becomes detached togetherwith the cover 8.

When the device is being opened, the finger grip unit 9 will be held inone hand and the cover 8 in the other. After it has been opened, thecontainer can be held by one hand and used forthwith without any need totouch the needle hub 5. l m

In the case of a syringe to be used for taking samples of body uids, thearrangement of the needle hub, needle and cover may be as describedabove, lbut the sealed container will be wholly or partly filled withair or evacuated.

Referring to FIGS. 3 and 4, a flexible hollow container 21 made, forexample, from polyethylene has a short hollow projection 22 at one endand a longer hollow projection 23 at its other end. The container ismade with the endA wall of the projection 22 open for filling and theend wall of the projection 23 closed. After filling, the opening in theend wall of the projection 22 is sealed, e.g. by heat.

The hollow projection 23 of the container is made |with an externalscrew thread which engages with the internal screw tread of a nozzle 24.

The nozzle 24 is made so that a short hollow needle 25, mounted in aferrule 26, may be assembled into its outer end and so arranged that,when the hollow projection 23 of the container 21 is screwed into thenozzle 24 more than a predetermined distance, the mounted needle 25 willpierce the end wall of the hollow projection 23.

The nozzle 24 is made of a rigid material such as, for example,polystyrene and is provided with fine longitudinal serrations, shown at27.

A protective cover 28 made of a soft flexible material such as, forexample, polyethylene can be fitted over the nozzle 24 so that a part 30thereof engages closely with the longitudinal serrations 27. Theinterior diameter of that part 31 of the cover 28 which extends betweenthe part 30 and the open end of the cover is enlarged so that there is asmall clearance between the serrated circumference of the nozzle 24 andthe interior surface of the said part 30. Consequently, an annular step32 is also formed between the parts 30 and 31.

When supplied ready for use, the container 21 is sealed with the druginside, the nozzle 24 with the needle 25 mounted therein as alreadydescribed is screwed onto the end of the hollow projection 23 such adistance that the tip of the needle 25 is close to, but not in contactwith, the end wall of the hollow projection 23 and the cover 28 ispushed over the nozzle 24, tightly engaging the serrations 27, until itsopen end engages a shoulder 29 on the container 21. The assembly is thensealed in an outer package (not shown), composed for example ofaluminium/polythene foil laminate, and the entire package is sterilizedby gamma radiation.

To use the device, the outer wrapping is removed and discarded. Thedevice can then safely be handled since the nozzle-end is protected fromthe users hands by means of the cover 28. To pierce the end of thehollow projection 23 of the container and at the same time remove thecover 28, the container 21 is rotated relatively to the cover 28 in sucha direction as to cause the nozzle 24 to be screwed further on to thehollow projection 23. The rotation of the cover 28 is transmitted to thenozzle 24 by the engagement of the longitudinal serrations 27 in thelatter with the soft material of the cover, while at the same time theseserrations allow longitudinal movement of the cover 28 relative to thehollow projection 23. When the cover 28 is rotated relatively to thecontainer 21, the nozzle 24 is screwed onto the hollow projection 23 ofthe container, thus causing the needle 25 to penetrate through the endwall of the said projection 23, but since the cover 28 is prevented frommoving closer to the container 21 by the abutment of the open end of thecover 28 against the shoulder 29, the nozzle 24 will move towards theopened end of the cover 28 until it is screwed fully home on theprojection 23, as shown in FIG. 4. The nozzle 24 will then lose itsdriving engagement with the cover 28, due to the serrations 27 on thenozzle having been displaced past the annular step 32 into a positionopposite the enlarged diameter interior surface part 31 of the cover.The final breaking of the frictional engagement between the cover 28 andthe nozzle 24 occurs when the nozzle 24 is screwed fully home, so thatrotation of the nozzle relatively to the cover 28 must take place if theaction of rotating the container relatively to the cover is continued.

As soon as the frictional engagement between the cover 28 and the nozzle24 is broken, the cover 28 becomes freely removable in the directionaway from the container 21.

Before the cover 28 cornes away, the nozzle 24 will have been firmlyscrewed onto the hollow projection 23 of the container, thus coveringthe screw thread on the hollow projection and producing a rigidassembly.

When the device is being opened, the cover 28 will be held in one handand the container 21 in the other. After it has been opened, thecontainer 21 lwill still be held by one hand and can be used forthwithwithout moving the fingers and with no need to touch the nozzle 24.

The embodiment illustrated in FIGS. and 6, differs from that illustratedin FIGS. 3 and 4 in that the serrated portion 27 of the nozzle 24' andthe interior surface 30 of the cover 28 are both formed with a slightinward taper in the direction away from the container 21. Thus, in theassembly as supplied to the user (FIG. 5), a rotary driving connectionis provided between the tapered serrated portion 27 of the nozzle 24'and the interior surface part of the cover 28', which driving connectionnevertheless permits relative axial displacement of the nozzle 24 withrespect of the cover 28. When, however, the nozzle 24 has been screwedfirmly home, as shown in FIG. 6, this rotary driving connection will bedisengaged, due to the smaller diameter part of the serrated portion 27of the nozzle 24' having been displaced into a position within thelarger diameter part of the interior of the cover 28', and the cover 28can be freely removed.

What is claimed is:

1. A medical appliance, comprising a sealed, eXible-walled, hollowcontainer having a closed-ended, screw-threaded hollow projection,

a grip unit surrounding the container,

a needle mounting of relatively rigid material having an internalscrew-thread engaged with the outer end part of the screw-threadedhollow projection,

a hollow needle mounted in the outer end part of the needle mounting andhaving a pointed end part extending through the interior thereof towardsthe closed end of the hollow projection,

a hollow cover removably and rotatably mounted on the grip unit andenclosing the hollow projection, the needle mounting and the hollowneedle,

and coupling means for transmitting rotation from the cover to theneedle mounting, while permitting axial displacement of the needlemounting with respect to the cover, so as to cause the needle mountingto be screwed a predetermined distance along the hollow projection foreffecting the piercing of the closed end of the latter by the saidpointed end part of the hollow needle,

the container having an annular abutment surface coaxial with the hollowprojection and serving to limit axial sliding movement of the covertowards the container, and

the coupling means being, arranged to become disconnected when theneedle mounting has been screwed through the said predetermined distancealong the hollow projection.

2. A medical appliance according to claim 1, wherein the cover is madeof relatively soft material, and

the rotary driving connection is formed by longitudinal serrations onthe outer surface of the needle mounting which engage in an interiorsurface part of the cover.

3. A medical appliance according to claim 2, wherein a part of the coverbetween the part thereof 'by which it is rotatably mounted on thecontainer and the said interior surface part is of enlarged internaldiameter, 'and an annular step formed between said first-mentioned andlast-mentioned parts is so located that the rotary driving connectionbetween the nozzle and the cover is disengaged when the nozzle isscrewed fully home after the needle has pierced the closed end of thehollow projection.

4. A medical appliance according to claim 2, wherein both the interiorsurface of the cover and the serrated external surface of the needlemounting are tapered inwardly in the `direction away from the containerso that the rotary driving connection between the nozzle and the coveris disengaged when the nozzle is screwed fully home after the needle haspierced the closed end part of the hollow projection.

5. A medical appliance according to claim 1 in which lsaid hollow fingergrip unit surrounds the front part of the container, and

ratchet drive means between the nger grip and the cover so that rotationof the finger grip in only one direction relatively to the container istransmitted to the cover.

6. A medical appliance according to claim 5, wherein an interior endsurface of the finger grip unit is arranged to engage an annular thrustsurface on the container, and

cooperating end thrust surfaces are provided on the finger grip unit andcover adjacent the ratchet drive so that the cover is located throughthe intermediary of the finger grip unit against axial displacementtowards the container.

References Cited FOREIGN PATENTS 210,267 1/1957 Australia.

LAWRENCE W. TRAPP, Primary Examiner G. F. DUNNE, Assistant Examiner U.S.C1. X.R.

